BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 4973373 · Received August 5, 2015

    Report

    Report Number
    1721504-2015-00139
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC
    Product Code
    DQO
    PMA / PMN Number
    K031691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND THE TIP OF THE WIRE WAS FOUND TO BE IN TACT. NO SEPARATION WAS FOUND ON THE TIP OF THE RETURNED UNIT. SINCE THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE PERFORMED. THE COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE TIP OF THE WIRE SEPARATED FROM THE SHAFT OF THE WIRE DURING USE. THE USER WAS UNSURE WHAT TYPE OF PROCEDURE WAS BEING PERFORMED AT THE TIME OF FAILURE. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS YET BEEN PROVIDED BY THE USER. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517692 MERIT CUSTOM KIT CUSTOM KIT DQO MERIT MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1